Trial Outcomes & Findings for Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults. (NCT NCT06996301)
NCT ID: NCT06996301
Last Updated: 2025-09-11
Results Overview
The number (and percentage) of subjects in each study arm with favorable clinical outcomes (FCl) at the EOS visit. The FCl was defined as a patient's clinical response, assessed by the treating investigator, indicating either clinical improvement or cure. Clinical improvement was defined as the resolution of at least one symptom of cUTI present at baseline, absence of new cUTI symptoms, and/or avoidance of parenteral antibiotic therapy following randomization. Clinical cure was defined as the complete resolution of all acute signs and symptoms of cUTI present at baseline, to the extent that no further antimicrobial therapy (either IV or oral) was required for the treatment of the cUTI.
COMPLETED
NA
773 participants
at End Of Study (EOS) visit (Day 28)
2025-09-11
Participant Flow
Between July 2023 and April 2024, 824 patients were screened, and 773 were randomized with informed consent. Both PCR and C\&S testing were performed for all enrolled participants (n = 773) before randomization into one of the two study arms
Participant milestones
| Measure |
PCR Arm
Treatment guided by the PCR results
|
C&S Arm
Treatment guided by the C\&S results
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
376
|
|
Overall Study
COMPLETED
|
193
|
169
|
|
Overall Study
NOT COMPLETED
|
204
|
207
|
Reasons for withdrawal
| Measure |
PCR Arm
Treatment guided by the PCR results
|
C&S Arm
Treatment guided by the C\&S results
|
|---|---|---|
|
Overall Study
Patients with negative microbiological evidence by both diagnostic methods
|
54
|
54
|
|
Overall Study
Patients with discordant diagnostic results
|
107
|
90
|
|
Overall Study
Lost to Follow-up
|
31
|
56
|
|
Overall Study
Withdrawal by Subject
|
12
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PCR Arm
n=397 Participants
Treatment guided by the PCR results
|
C&S Arm
n=376 Participants
Treatment guided by the C\&S results
|
Total
n=773 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=397 Participants
|
0 Participants
n=376 Participants
|
0 Participants
n=773 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=397 Participants
|
49 Participants
n=376 Participants
|
101 Participants
n=773 Participants
|
|
Age, Categorical
>=65 years
|
345 Participants
n=397 Participants
|
327 Participants
n=376 Participants
|
672 Participants
n=773 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=397 Participants
|
263 Participants
n=376 Participants
|
535 Participants
n=773 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=397 Participants
|
113 Participants
n=376 Participants
|
238 Participants
n=773 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: EOS Population: This group included all enrolled patients who completed the study procedures, including the treating investigators' evaluation.
The number (and percentage) of subjects in each study arm with favorable clinical outcomes (FCl) at the EOS visit. The FCl was defined as a patient's clinical response, assessed by the treating investigator, indicating either clinical improvement or cure. Clinical improvement was defined as the resolution of at least one symptom of cUTI present at baseline, absence of new cUTI symptoms, and/or avoidance of parenteral antibiotic therapy following randomization. Clinical cure was defined as the complete resolution of all acute signs and symptoms of cUTI present at baseline, to the extent that no further antimicrobial therapy (either IV or oral) was required for the treatment of the cUTI.
Outcome measures
| Measure |
PCR Arm
n=193 Participants
Treatment guided by the PCR results
|
C&S Arm
n=169 Participants
Treatment guided by the C\&S results
|
|---|---|---|
|
Favorable Clinical Outcomes (FCl)
|
170 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: EOS Population: This group included all enrolled patients who completed the study procedures, including the treating investigators' evaluation.
Number (and percentage) of subjects with microbiological eradication at the EOS, defined as achieving a quantitative urine culture at the EOS indicating a reduction of all uro-pathogens present at baseline to \<10\^5 colony forming unit per milliliter (CFU/mL) and the absence of baseline pathogens detected by EOS urine PCR (Cq \> 33)
Outcome measures
| Measure |
PCR Arm
n=193 Participants
Treatment guided by the PCR results
|
C&S Arm
n=169 Participants
Treatment guided by the C\&S results
|
|---|---|---|
|
Microbiological Eradication
|
120 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: EOS Population: This group included all enrolled patients who completed the study procedures, including the treating investigators' evaluation.
Subjective measurement of treating investigator satisfaction score through a questionnaire (5 questions) at EOS, evaluated factors such as (1) result availability/timeliness, (2) clarity of result interpretation, (3) clinical decision-making utility, (4) overall test satisfaction, and (5) perceived impact on patient outcomes versus comparator. Scale information Score Interpretation: Each item scored 1-5; higher scores reflect greater diagnostic and therapeutic value. Total score meaning: * ≥20: Good clinical utility. * 10-19: Moderate utility. * 1-9: Poor utility.
Outcome measures
| Measure |
PCR Arm
n=193 Participants
Treatment guided by the PCR results
|
C&S Arm
n=169 Participants
Treatment guided by the C\&S results
|
|---|---|---|
|
Treating Investigator Satisfaction Score
|
23.95 score on a scale (1-25)
Standard Error 1.96
|
20.64 score on a scale (1-25)
Standard Error 4.12
|
SECONDARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: EOS Population: This group included all enrolled patients who completed the study procedures, including the treating investigators' evaluation.
Comparison of turnaround time between molecular diagnostic procedures and conventional diagnostic
Outcome measures
| Measure |
PCR Arm
n=193 Participants
Treatment guided by the PCR results
|
C&S Arm
n=169 Participants
Treatment guided by the C\&S results
|
|---|---|---|
|
Turnaround Time
|
49.68 hours
Interval 2.41 to 152.53
|
104.4 hours
Interval 48.21 to 592.53
|
SECONDARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: EOS Population: This group included all enrolled patients who completed the study procedures, including the treating investigators' evaluation.
Overall agreeability between the diagnostic results generated by PCR versus C\&S as assessed by discordant analysis
Outcome measures
| Measure |
PCR Arm
n=193 Participants
Treatment guided by the PCR results
|
C&S Arm
Treatment guided by the C\&S results
|
|---|---|---|
|
Overall Agreeability
Sensitivity %
|
88.6 percentage
|
—
|
|
Overall Agreeability
Specificity %
|
62.91 percentage
|
—
|
SECONDARY outcome
Timeframe: at End Of Study (EOS) visit (Day 28)Population: Patients with discordant results PCR Arm : PCR(+), CS(-) \& C\&S Arm : PCR(-), CS(+) Note: PCR Arm: No patients were identified as PCR(-), CS(+). C\&S Arm: A total of 68 patients were PCR(+), CS(-). Their clinical outcomes were not reported in this study, as they were managed with empiric therapy rather than pathogen-directed treatment.
Assessment of the favorable clinical outcome of patients with discordant results \[PCR(+), CS(-) and PCR(-), CS(+)\] Patients with discordant results \[PCR(+), CS(-) and PCR(-), CS(+)\] were excluded from the primary endpoint analysis and their outcome is presented here as a secondary analysis
Outcome measures
| Measure |
PCR Arm
n=102 Participants
Treatment guided by the PCR results
|
C&S Arm
n=14 Participants
Treatment guided by the C\&S results
|
|---|---|---|
|
Favorable Clinical Outcome of Patients With Discordant Results
|
79 Participants
|
10 Participants
|
Adverse Events
PCR Arm
C&S Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place